2. DOSAGE AND ADMINISTRATION

2.1. Standard protocol for IM administration: 1 vial 1-3 times a week according to severity and clinical progress.
2.2. Standard protocol according to mesotherapy technique using 1 vial per treatment: 2 treatments for the first 2 weeks, 1 treatment a week till pain relief (average 8-10 sessions). For chronic pathologies: continue 1 treatment a week for 1 month till pain relief, then 1 treatment a month.
Select application site according to trigger points, tender points, referred pain zones, acupuncture points, key nerve points, or “local pain points”. Using a 13 mm, 30G or a 4 mm, 27G needle, make the classic intradermal injection according to mesotherapy technique.
Discard unused solution
2.3. Opening of Vials: Use sterile needles and sterile syringe. Do not reuse. Do not use if foreign particles are present. Draw 1 cc of air into syringe, insert needle into vial inject air and withdraw the solution.

4. CONTRAINDICATIONS

4.1. There is no history of hypersensitivity or allergy to GUNA®-POLYARTHRITIS. However patients with a known hypersensitivity or allergy to any ingredient should be tested before use. Make a spot injection (0.1ml) into the forearm and observe for any reactions for 1 hour.

5. WARNINGS AND PRECAUTIONS

5.1. Joint pain requires differential diagnosis for acute or subacute viral diseases, bacterial infection, pain due to overweight (leg joints) hyperuricemia syndrome, gout, and referred pain.
5.2. Patients with known sensitivity to salycilates should be monitored closely during the therapy, and should only be treated after successful application of a test dose without adverse effects.
5.3. Skin cleansing/disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation

6. ADVERSE REACTIONS

6.1. The most common mild adverse reaction is slight reddening at the injection site due to the mechanical effect of the needle or a superficial skin reaction of mild erythema.

7. DRUG INTERACTIONS

7.1. None Known.

8. USE IN SPECIFIC POPULATIONS

8.1 Pregnancy: Pregnancy category C. Animal reproduction studies have not been conducted with GUNA®- POLYARTHRITIS. GUNA®- POLYARTHRITIS should not be given to a pregnant woman.
8.2 Nursing mothers: It is not known whether any of the ingredients in GUNA®- POLYARTHRITIS are secreted in human milk. However, since many drugs are secreted in human milk, caution should be exercised when GUNA®- POLYARTHRITIS is administered to a nursing woman.
8.3 Pediatric use: No restrictions.
8.4 Geriatric use: No restrictions.

9. DRUG ABUSE AND DEPENDENCE

9.1. No Known.

10. OVERDOSAGE

10.1. No Known.

11. DESCRIPTION

11.1. GUNA®-POLYARTHRITIS is a sterile solution made with isotonic sodium chloride solution. It is a homeopathic complex medicine, whose active ingredients have been selected in order to promote 2 main activities: Detoxification of the connective tissue matrix; Pain modulation through stimulation of the physiological mechanism of pain control. Attenuation of the biological substrates acts to target the area of activity of the product.

12. CLINICAL PHARMACOLOGY

12.1. Mechanism of Action
Due to the homeopathic nature of the active ingredients, receptors may be activated by feedback regulation. Beta-endorphins at the 4C dose activate the membrane receptors for endogenous endorphins that play a key role in pain relief. Anti IL-1 induces a down regulation of IL-1 inflammatory activity.
12.2. Pharmacodynamics
The physiological effects of GUNA®-POLYARTHRITIS are due to the action of the ingredients, as described in the Homeopathic Materia Medica.
In Homeopathy there is no direct relationship between dose and effect, but rather there is a relationship between attenuation and a balancing effect on biochemical pathways.
In GUNA®-POLYARTHRITIS the attenuation of each ingredient has been selected according to the Arndt-Schulz Principle (inverted effect law). Attenuation of the physiological ingredients promotes membrane receptor feedback in order to normalize altered biological pathways. In Addition the attenuation technique activates the low dilutions and stabilizes clinical activity of the compound.
12.3. Pharmacokinetics
The Homeopathic attenuation provides complete bioavailability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

13.1. GUNA®-POLYARTHRITIS has no level of toxicity due to the attenuation of the ingredients.